Heart/Mediastinal Ratio Study for Potential Equivalence of Heart/Mediastinal Ratios at One and Two Hours to the Traditional Heart/Mediastinal Ratio Obtained at Four Hours
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | October 2011 |
| Contact: | Maria M Chester, RN |
| Email: | mchest@lsuhsc.edu |
| Phone: | (504) 464-8500 |
The purpose of this study is to determine if the measurement (with a standard nuclear
camera) of radioactivity normally present in the nervous system of your heart at four hours
after the injection of radioactive drug for your diagnostic I-123 MIBG scan is any different
than radioactivity measured in your heart at one and/or two hours after your diagnostic scan
injection. If equivalent information to the conventional 4 hr H/M ratio could be collected
by obtaining H/M ratios at 1 or 2 hour windows, it would greatly facilitate patient
acceptance of the procedure since the requirements for obtaining a valid H/M ratio would be
considerably less time-consuming.
One hour before being injected with the drug (I-123 MIBG) for your MIBG scan, you will be
given a standard dose of non-radioactive iodine (Lugol's solution) to block your thyroid
from receiving the small amount of radiation that is a normal part of the MIBG scan. You
will then be injected with MIBG, and you will have 10 minute pictures of your chest at 15
minutes, 1 hour, 2 hours, and 4 hours in addition to the standard 24 hour pictures. These
pictures will be taken in the Nuclear Medicine Section, Department of Radiology at Ochsner
Medical Center-Kenner. The experimental (research) part of this study is having the extra
10-minute pictures of your chest at 15 minutes, 1 hour, 2 hours, and 4 hours. Normally,
pictures are only taken 24 hours after the injection. Therefore the research is limited to
the four extra pictures taken, and involve no additional injections or I-123 drug beyond
that you will be receiving regardless of whether you are part of this research.
camera) of radioactivity normally present in the nervous system of your heart at four hours
after the injection of radioactive drug for your diagnostic I-123 MIBG scan is any different
than radioactivity measured in your heart at one and/or two hours after your diagnostic scan
injection. If equivalent information to the conventional 4 hr H/M ratio could be collected
by obtaining H/M ratios at 1 or 2 hour windows, it would greatly facilitate patient
acceptance of the procedure since the requirements for obtaining a valid H/M ratio would be
considerably less time-consuming.
One hour before being injected with the drug (I-123 MIBG) for your MIBG scan, you will be
given a standard dose of non-radioactive iodine (Lugol's solution) to block your thyroid
from receiving the small amount of radiation that is a normal part of the MIBG scan. You
will then be injected with MIBG, and you will have 10 minute pictures of your chest at 15
minutes, 1 hour, 2 hours, and 4 hours in addition to the standard 24 hour pictures. These
pictures will be taken in the Nuclear Medicine Section, Department of Radiology at Ochsner
Medical Center-Kenner. The experimental (research) part of this study is having the extra
10-minute pictures of your chest at 15 minutes, 1 hour, 2 hours, and 4 hours. Normally,
pictures are only taken 24 hours after the injection. Therefore the research is limited to
the four extra pictures taken, and involve no additional injections or I-123 drug beyond
that you will be receiving regardless of whether you are part of this research.
Inclusion Criteria:
1. NET patients who are potential candidates for I-131 MIBG therapy, and are having
whole body I-123 MIBG scintigraphy as standard of care.
2. Male or female patients ≥ 18 years of age.
3. Written informed consent from patients obtained in accordance to local guidelines.
4. History and physical exam indicating low likelihood, < 10 %, of any significant
cardiac disease.
5. Echocardiogram within normal limits, including absence of valvular disease and normal
LVEF.
6. Serum BNP within normal limits. -
Exclusion Criteria:
1. Patients on drugs which interfere with MIBG uptake - tricyclic antidepressants,
phenylpropanolamine, pseudephredine, phenylephrine, sympathomimetics, amphetamines,
reserpine, thorazine and thiothixines, calcium channel blockers, cocaine, and
long-acting beta blockers.
2. >10% likelihood of any significant heart disease, including myocardial ischemia,
cardiomyopathies, uncontrolled hypertension, congestive heart failure and valvular
heart disease, e.g. see "Likelihood of Assessment of Coronary Artery Disease" below.
3. History of uncontrolled diabetes mellitus
4. Signs/symptoms of neurological diseases (e.g., Parkinsonian syndromes) or other
disease known to affect the sympathetic nervous system.
5. Female patients who are pregnant or nursing (lactating), or adults of reproductive
potential who are not using effective birth control methods. If there is any question
of pregnancy, a serum bHCg will be collected.
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